Often celebrated as a model of development in Africa, Botswana nonetheless endured a severe HIV epidemic. This article describes the singularity of the Botswana experience in facing AIDS and creating the widest possible access to antiretroviral medications for its citizens. Through exploration of different sets of actors and the construction of their ethics of treatment, it is possible to examine how free and universal access was created within the national antiretroviral program. This article underscores the importance of the site and (...) the local dynamics in the advent of an ethics of access to treatment for Botswana citizens. At the intersection of national citizenship, pharmaceutical philanthropy, and biomedical collaborations, Botswana is an exemplary case (one of the first and unique in its kind) of global health programs for access to drugs in which patients' rights are tied to science and pharmaceutical development. As such it also bears some limitations and concerns over its sustainability. (shrink)

This paper analyses the way in which being in possession of an adequate range of options is an essential component of autonomy. I discuss the way in which the conceptualisation of options in terms of basic rights might assist this argument, and apply these ideas to HIV/AIDS clinical research in the developing world. Finally, I suggest that mechanisms should be put in place through which vulnerable research participants can express their views about the relationship between the research in which they (...) are involved, and needs of a worthwhile life. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

The Kennedy Krieger lead paint study received a lot of attention after a US Court of Appeals ruled that a parent cannot consent to the participation of a child in non-therapeutic research. The ruling has raised fears that, if it goes unchallenged, valuable research might not proceed and ultimately all children would be harmed. The author discusses significant aspects of the study that have been neglected, and argues that the study was unethical because it involved injustice and its design meant (...) that the study lacked importance and value. Issues of benefit, risk, and consent are vital, but it is sometimes a mistake to consider these issues before settling questions about justice and the importance and value of a research project. The author concludes by offering a strategy for researchers and reviewers of research to appreciate, in a vivid way, the implications of research participation. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic (...) bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

Ethical problems are common in clinical medicine, so medical volunteers who practice clinical medicine in developing countries should expect to encounter them just as they would in their practice in the developed world. However, as this article argues, medical volunteers in developing countries should not expect to encounter the same ethical problems as those that dominate Western biomedicine or to address ethical problems in the same way as they do in their practice in developed countries. For example, poor health and (...) advanced disease increase the risks and decrease the potential benefits of some interventions. Consequently, when medical volunteers intervene too readily, without considering the nutritional and general health status of patients, the results can be devastating. Medical volunteers cannot assume that the outcomes of interventions in developing countries will be comparable to the outcomes of the same interventions in developed countries. Rather, they must realistically consider the complex medical conditions of patients when determining whether or not to intervene. Similarly, medical volunteers may face the question of whether to provide a pharmaceutical or perform an intervention that is below the acceptable standard of care versus the alternative of doing nothing. This article critically explores the contextual features of medical volunteer work in developing countries that differentiate it from medical practice in developed countries, arguing that this context contributes to the creation of unique ethical problems and affects the way in which these problems should be analyzed and resolved. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise. (shrink)

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities (...) and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems. (shrink)

In a White House ceremony on May 16, 1997, President Clinton issued an apology on behalf of the nation for the Tuskegee Syphilis Study, a forty-year research project in which African-American men were deceived and denied treatment in order to document the natural course of syphilis. Reflection on this occasion can give us pause to take pride in the progress made toward more ethical research with humans. The President's apology is perhaps the most public of a number of recent events (...) representing a renewed attention to ethics in research with human participants. Alongside it stand the efforts of treatment activists for people with acquired immune deficiency syndrome and the revelations of the human radiation experiments. In 1995, President Clinton called for the creation of the National Bioethics Advisory Commission, which was charged with a host of projects aimed at investigating the organization and function of the federal system for overseeing human subjects research in the United States, and giving guidance on specific forms of research. (shrink)

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland (...) version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that (...) there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

A report by the Nuffield Council on Bioethics, contrary to the Declaration of Helsinki, permits most important research initiatives in developing countries.The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons need to be given for not (...) giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world. (shrink)

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a four month (...) period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants. (shrink)

The vagueness or imprecision of ‘the normal’ allows it to be exploited for various purposes and political ends. It is conspicuous in both medicine and athletics; I am going to try to say something about the normal in each of these areas. In medicine the idea of the normal is often deployed in understanding what constitutes disease and hence, as some see it, in determining the role of physicians, in determining what is or ought to be covered by insurance, and (...) in underwriting certain views on social justice. In athletics the use of performance enhancing substances raises different sorts of questions about the normal, especially when it comes to deciding what constitutes an enhancement and which enhancements, if any, are acceptable. (shrink)

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing treatments like zidovudine. This scenario is first stated as generally as possible, before three ethical principles found in the Belmont Report, itself a sharpening of the Helsinki Declaration, are stated. These three principles are the Principle of Utility, the Principle of Autonomy and the Principle of (...) Justice. These are taken as voices of moral imperative. But although each has intuitive appeal, it can be shown that there are possible scenarios in which they give conflicting prescriptions. To achieve consistency, one must be subordinate to the others. The voice of utility is taken as subordinate to those of justice and autonomy and it is shown that given plausible assumptions about the level of poverty and education in the developing country targeted, the experiment is ruled morally wrong in the name of both justice and autonomy. Moreover, it is argued that no justification can be found for the inclusion of a placebo group, when strictly defined. By contrast, a ‘no- treatment’ control arm might be justified, but only when the demands of autonomy are satisfied, demands that are more stringent than they might appear. A utilitarian defence of the experiment is examined, namely that the would-be participants are in a no-loss situation, and it is shown that this defence is seriously flawed. Finally, it is concluded that there is no justification for amending the Declaration of Helsinki. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

In this paper, we argue that lack of access to the fruits of modern medicine and the science that informs it is an important and neglected topic within bioethics and medical ethics. This is especially clear to those working in what are now termed 'resource-poor settings'- to those working, in plain language, among populations living in dire poverty. We draw on our experience with infectious diseases in some of the poorest communities in the world to interrogate the central imperatives of (...) bioethics and medical ethics. AIDS, tuberculosis, and malaria are the three leading infectious killers of adults in the world today. Because each disease is treatable with already available therapies, the lack of access to medical care is widely perceived in heavily disease-burdened areas as constituting an ethical and moral dilemma. In settings in which research on these diseases are conducted but there is little in the way of therapy, there is much talk of first world diagnostics and third world therapeutics. Here we call for the 'resocialising' of ethics. To resocialise medical ethics will involve using the socialising disciplines to contextualise fully ethical dilemmas in settings of poverty and, a related gambit, the systematic participation of the destitute sick. Clinical research across steep gradients also needs to be linked with the interventions that are demanded by the poor and otherwise marginalised. We conclude that medical ethics must grapple more persistently with the growing problem posed by the yawning 'outcome gap' between rich and poor. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

: The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard care in (...) medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Volume 20, Issue 5, June 2020, Page 77-79.

The conduct of clinical trials involving placebo in developing countries in the presence of an existing effective treatment triggered an intense debate on the standard of care to be provided to those populations. Charges of exploitation of vulnerable groups and double standards have been raised by several scholars. In response to these concerns, the Declaration of Helsinki was revised in 2000, 2008 and 2013, eventually endorsing the golden standard instead of the local standard of care. The European Union adopted a (...) strategy on the Marketing Authorization of medicinal products tested in third countries, improved with Regulation 536/2014 on clinical trials on medicinal products for human use. Additional rules have been enacted by other international organizations. The present paper has the aim of analyzing scope and content of existing international and regional standards on placebo. (shrink)

Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol (...) and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. Trial registration Current Controlled Trials ISRCTN64716212. (shrink)

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting doctoral and postdoctoral training and career (...) paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...) ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (shrink)

BackgroundThe ethical concerns associated with HIV prevention and treatment research have been widely explored in South Africa over the past 3 decades. However, HIV cure research is relatively new to the region and significant ethical and social challenges are anticipated. There has been no published empirical enquiry in Africa into key informant perspectives on HIV cure research. Consequently, this study was conducted to gain preliminary data from South African HIV clinicians, researchers and activists.MethodsIn-depth interviews were conducted on a purposive sample (...) of fourteen key informants in South Africa. Audiotaped interviews were transcribed verbatim with concurrent thematic analysis. The perspectives of HIV clinicians, researchers and activists were captured. Analyst triangulation occurred as the data were analysed by three authors independently.ResultsThe rapid evolution of HIV cure research agendas was prominent with participants expressing some concern that the global North was driving the cure agenda. Participants described a symbiotic relationship between cure, treatment and prevention research necessitating collaboration. Assessing and managing knowledge and expectations around HIV cure research emerged as a central theme related to challenges to constructing ‘cure’ - how patients understand the idea of cure is important in explaining the complexity of cure research especially in the South African context where understanding of science is often challenging. Managing expectations and avoiding curative misconception will have implications for consent processes. Unique strategies in cure research could include treatment interruption, which has the potential to create therapeutic and ethical conflict and will be perceived as a significant risk. Ethical challenges in cure research will impact on informed consent and community engagement.ConclusionsIt was encouraging to note the desire for synergy amongst researchers and clinicians working in the fields of prevention, treatment and cure. Translation of complex HIV cure science into lay language is critical. Moving forward, RECs must be adequately constituted with scientific expertise and community representation when reviewing cure protocols. It is hoped that knowledge and resource sharing in the context of collaboration between research scientists working in cure and those working in treatment and prevention will accelerate progress towards cure. (shrink)

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee, was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health research ethics committees.Objective. (...) To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC.Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country.Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor.Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them. (shrink)

It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous “double standard of care” case study in order to offer (...) novel consideration of the placebo orthodoxy that underlies much of the ethical debate. This majority view found in medical research is that placebo-controlled trials are methodologically superior to comparative trials that use active controls. I challenge this orthodoxy and argue that lives were unnecessarily lost in these trials as a result. Furthermore, current HIV research on vaccines and microbicides is now poised to repeat the error of subscribing to the placebo orthodoxy. (shrink)

The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. Methods (...) We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (shrink)

The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is (...) justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. (shrink)

This essay explores the claim that bioethics has become a mode of biopolitics. It seeks to illuminate one of the myriad of ways that bioethics joins other institutionalized discursive practices in the task of producing, organizing, and managing the bodies—of policing and controlling populations—in order to empower larger institutional agents. The focus of this analysis is the contemporary practice of transnational biomedical research. The analysis is catalyzed by the enormous transformation in the political economy of transnational research that has occurred (...) over the past three decades and the accompanying increase in the numbers of human bodies now subjected to research. This essay uses the work of Michel Foucault, particularly his notion of docile bodies, to analyze these changes. Two loci from the bioethics literature are explored—one treating research in the United States and one treating research in developing countries. In the latter, we see a novel dynamic of the new biopolitics: the ways in which bioethics helps to create docile political bodies that will police themselves and who will, in turn, facilitate the production of docile human bodies for research. (shrink)

In July 1997, the voting representatives at the National Consensus Conference on Bioethics in Health Research voted unanimously to adopt the proposed Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. This vote represented the culmination of a three-year journey towards the development of a coherent and cohesive framework for the ethical review of health research involving human subjects in Uganda.Attendees at the NCC included both voting representatives and non-voting participants. Voting representatives had been designated by the (...) institutional entity with which they were affiliated to represent that entity at the NCC and to voice the concerns and opinions of the entity and its constituents. (shrink)

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had (...) disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies. (shrink)

Book Review of 'Ethics and AIDS in Africa: The Challenge to Our Thinking' By Anton A. van Niekerk and Loretta M. Kopelman (Eds).

BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern (...) bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)

During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. In this article, (...) we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard. (shrink)

Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...) trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings. (shrink)

ABSTRACT This module is designed to sensitise you to the special needs of participants who belong to populations that are more vulner.

We discuss how a novel can illuminate the moral dimensions of science and healthcare. The critical distance afforded by the novel pro.

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...) the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)